Understanding Mechanisms of Normal and Disordered Defecation

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT03842007
Status
Recruiting
Apply to this trial

Conditions

  • Constipation

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Rectal Barostat Study — DIAGNOSTIC_TEST
    Contractions will be recorded with a balloon inserted into the rectum and inflated
  • Fecoflowmetry — DIAGNOSTIC_TEST
    Rectum will be filled with a small amount of paste.Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.

Study Details

Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.

Key Dates

Start date
Jan 29, 2019
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Healthy Individuals
    Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry
  • Active Comparator: Constipated Individuals
    60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry

Primary Outcome Measure

Rectal emptying [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Kelly J Feuerhak
[email protected]
507-255-6802
Adil E Bharucha, MD (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Rochester· Rochester, MN

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